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International regulators focus on medical software, including apps

I’ve always found the saying, “Be careful what you wish for; you might just get it” to be rather condescending. In a way it suggests that we are too stupid to manage our own affairs. But like any popular saying, it probably has a kernel of truth.

Frankly, I’m a little nervous about a request made by industry for international medical device regulators to focus on standalone software, including mobile medical apps. At the request of an international trade group, on March 21, 2013, the International Medical Device Regulators Forum (IMDRF) decided to pursue harmonization of the regulatory approach to standalone medical device software. Standalone software in healthcare, as most people use that term, would include mobile medical apps, clinical decision support software, electronic health records and any other software used in healthcare that does not drive a medical device (hence it stands alone.)

Many of the industrialized and developing nations around the world established IMDRF in 2011 to provide a forum to discuss future directions in medical device regulation, and harmonization at an international level. The IMDRF builds upon the work of the Global Harmonization Task Force.

IMDRF membership includes regulators from Australia, Brazil, Canada, China, European Union, Japan and the United States, as well as the World Health Organization (WHO). In the US, for example, FDA is the participant, and in the EU the representative is the European Commission Directorate -- General Health and Consumers. The recent IMDRF meeting that examined software took place in Nice (France) from 19 to 21 March 2013. The next meeting will take place in Brussels on 12-14 November 2013.

The IMDRF manages its agenda by formally adopting so-called work items. These work items then become the focus of activities between the full, semi-annual gatherings of the Forum. In 2012, at the fall meeting in Sydney, the DITTA (Global Diagnostic Imaging, Healthcare IT and Radiation Therapy Trade Association) recommended the creation of a work item dedicated to medical software. In an October 29, 2012 letter to IMDRF, DITTA wrote:

DITTA greatly appreciates the Management Committee’s further consideration during their session on 27 September of our proposal for a possible future IMDRF work item on medical software. Reasons which justified our suggested work item to IMDRF are that medical software is playing an increasingly greater role in medical technology in product-embedded software applications or in stand-alone software solutions. This includes but is not limited to aspects of software vulnerability with potential impact on patient safety. Therefore global harmonization of regulations and standards governing medical software is critical for patient safety as well as to the future innovation and prosperity of our industry.

Selecting standalone software as a work item is a big step as the 2-year-old forum only maintains about a half-dozen work items. Indeed, the most recent meeting only produced two new ones.

This is either a tremendous opportunity or a tremendous threat depending on whether you are an optimist or pessimist. I frankly don’t know what it is. Subject to what region you’re from, international harmonization can either raise the tide or lower it. Some folks worry that when regulators get together to compare notes on an issue the hurdles typically go up, kind of a regulatory arms race, but the positive side is that harmonization can be very helpful to international businesses.

Certainly there is a lot going on in the US with regard to mHealth regulation, but most people in the space can’t afford to simply ignore the rest of the world. Indeed, even if you’re only involved in US, this Forum has the potential to influence US regulation. Industry needs to be actively involved in all of these discussions to ensure the resulting regulation is sensible, and accommodates the innovation which is the lifeblood of mHealth. I just hope we like what we asked for.